Regulatory Affairs Specialist – LATAM – Johnson

3 semanas atrás

São Paulo, Brasil Johnson & Johnson Tempo inteiro

Titulo da Vaga: Regulatory Affairs Specialist – LATAM

Nome da Empresa: Johnson & Johnson

Localização: São Paulo – SP

Descrição da Vaga: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow. As a Regulatory Affairs Specialist, your primary objective is to develop and enhance a robust skill set that enables you to make value-added individual contributions to our organization. Working under moderate supervision, you will play a crucial role in ensuring the compliance of our new and modified products with regulatory and government standards worldwide, aligning with corporate policies and strategies. Working model: Hybrid (3 days at office) Scope: LATAM

Duties & Responsibilities:

  • Implements compliance with regulatory agency regulations by providing knowledge to enable products that are developed, manufactured, or distributed to meet regulatory agency requirements.
  • Completes thorough analysis and interpretation of scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market.
  • Applies in-depth knowledge on cross-functional project teams in the development of compliant policies and operational plans to ensure timely commercialization of new and modified products into key markets.
  • Identifies opportunities on input for product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process.
  • Completes detailed regulatory submissions required for new and existing product approvals and registrations.
  • Communicates Regulatory Affairs interpretation and feedback in support of federal, state, and/or international regulations by preparing documentation and reports to support internal and external audits.
  • Coaches more junior colleagues in techniques, processes and responsibilities.
  • Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
  • In partnership with Subregional Leader, supports the implementation of objectives for the Latin America countries under her/his scope, based on JJV business priorities, and regional regulatory strategies.
  • Manages local/regional projects ensuring that all information related to new/existing products are visible, ensuring that RA team has all information needed for planning.
  • Executes registration strategies for designated local/regional projects related to new/existing products, according to local regulation, approved licenses, and RA Country alignment.
  • Participates in team meetings related to projects under her/his regulatory responsibility.
  • Responds to product information related to local requests or designated regional projects.
  • Works with Subregional Leader to ensure rapid and timely approval of new products and continued Regulatory support of products marketed in the Latin America countries under her/his scope.
  • Controls expenses to support the preparation and management of RA budget for the Latin America countries under her/his scope.
  • Conducts activities concerned with the submission and approval of designated projects to government regulatory agencies in the Latin America countries under her/his scope.
  • Defines, requests, follows-up and obtains the documentation deliverables to assist with the local/regional designated projects for all countries with regulatory action.
  • Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance.
  • Prepares local/regional designated projects repository folder, creates the new or modified product guideline and shares folder and guideline with Country Owners to execute the regulatory action.
  • Represents Regulatory Affairs on cross-functional project teams under her/his scope.
  • In partnership with Subregional Leader, interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters.
  • Ensures timely and accurate promotional materials review and HA notification according to local advertising legal requirements.
  • Supports the evaluation of proposed product modifications for Regulatory impact and the completion of Regulatory Assessments, as needed.
  • Ensures the update and maintenance of products registration and listing.
  • Updates relevant global, local databases to ensure compliance.
  • Conducts searches of existing files for requested information.
  • Maintains and archives regulatory documentation.
  • In partnership with Subregional Leader, provides regulatory support to inspections/audits by producing requested documents or answering any inquiries for information.

Education & Experience:

  • Bachelor’s degree with a minimum of 5 years of Regulatory experience in a regulated industry (could include pharmaceutical, medical device, or associated consumer industries).
  • Advanced in English or Spanish (written and verbal).
  • Very strong regulatory knowledge of regulations in the region.

Skills:

  • Result-oriented, initiative, proactive.
  • Accountability and ownership.
  • Team player and collaboration.
  • Ability to prioritize multiple tasks and projects.
  • Good communication skills (collaborative approach), open-minded.
  • Able to analyze information with complex scope to make autonomous decisions and formulate clear advice.
  • Proven Data analysis experience.
  • Project management skills.
  • Systems: MDRIM/ Agile experience will be considered a plus.

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